Reata: Prior Approval Supplement for SKYCLARYS, Commercial Availability for Friedreich’s Ataxia

  Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” “our,” “us,” or “we”), a global, biopharmaceutical company focused on developing and commercializing novel therapies for patients with severe diseases, announced that the United States Food and Drug Administration (FDA) has approved the Prior Approval Supplement (PAS) to update the drug substance specification for SKYCLARYS^® (omaveloxolone), the first and only FDA approved drug for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older. With the approval of the PAS, SKYCLARYS is now available to patients with Friedreich’s ataxia in the United States.

https://www.biospace.com/article/releases/reata-pharmaceuticals-announces-approval-of-prior-approval-supplement-for-skyclarys-omaveloxolone-and-commercial-availability-of-skyclarys-for-patients-with-friedreich-s-ataxia/